Remede (Respicardia)

A Randomized Trial Evaluating the Safety and Effectiveness of the Remede System in Patients With Central Sleep Apnea

Remede (Respicardia) [NCT01816776]

Description: The primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by the remede system in subjects with moderate to severe central sleep apnea and optimal medical management, compared to outcomes in randomized control subjects receiving optimal medical management and implanted but inactive remede systems.

 

Device: Treatment Group (remede; phrenic nerve stimulation); Device: Control Group (Optimal Medical Therapy)

Primary Investigator: Beyerbach

Drug/Device Information
To evaluate the safety and effectiveness of the remede® system in moderate to severe central sleep apnea and optimal medical management
The remede® system is indicated for transvenous phrenic nerve stimulation to treat central sleep apnea
1:1 randomization to either immediate therapy initiation (Treatment group) or delayed therapy initiation (Control group)
Respicardia, Inc.